NCT06093256

Brief Summary

The aim of this research:

  1. 1.To analyze the possible influence of fixed orthodontic appliances on taste perception among patients undergoing conventional orthodontic treatment.
  2. 2.To objectively assess taste perception in patients with fixed orthodontic appliances using taste strips.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

October 27, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

October 16, 2023

Last Update Submit

October 25, 2023

Conditions

Taste PerceptionFixed Orthodontic Appliances

Keywords

Fixed Orthodontic AppliancesTaste AlterationsTaste Perception

Outcome Measures

Primary Outcomes (1)

  • Comparison of taste perception with the use of fixed orthodontic appliances

    Analysis of taste changes before and after orthodontic treatment using taste filter strips.

    Baseline and after 13 weeks

Interventions

Fixed orthodontic appliancesDEVICE

Taste sensation will be checked before and after fixed orthodontic therapy.

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

A total sample of 40 volunteers will be studied at 3 different time points. The sample size for the study was calculated based on the medium effect size obtained from the study by Mueller et al. (2003) by considering α error probability (0.05) and required power (1-β err prob) (0.93). While keeping in mind the resources and time limits to conduct the study.

You may qualify if:

  • Patients in orthodontic therapy by conventional fixed orthodontic treatment.
  • At least aged 15 years and over.

You may not qualify if:

  • Any patients with endocrine abnormalities (diabetes mellitus, thyroid gland dysfunction, Cushing's disease).
  • Any internal disorders (chronic renal failure, liver cirrhosis)
  • Middle ear infections.
  • Smoking patients.
  • Depression and xerostomia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (19)

  • Ajwa N, AlHammad A, AlAmmar L, AlMarjan M, AlShugair T, AlManie L, Bangalore D. The Influence of Orthodontic Treatment Need on Oral Health-Related Quality of Life among 12-18-Year-Old Adolescents in Riyadh. Healthcare (Basel). 2022 Oct 28;10(11):2153. doi: 10.3390/healthcare10112153.

    PMID: 36360492BACKGROUND

  • Almotairy N, Almutairi F. A Nation-wide Prevalence of Malocclusion Traits in Saudi Arabia: A Systematic Review. J Int Soc Prev Community Dent. 2022 Jan 29;12(1):1-11. doi: 10.4103/jispcd.JISPCD_251_21. eCollection 2022 Jan-Feb.

    PMID: 35281679BACKGROUND

  • Bernabe E, Sheiham A, de Oliveira CM. Impacts on daily performances related to wearing orthodontic appliances. Angle Orthod. 2008 May;78(3):482-6. doi: 10.2319/050207-212.1.

    PMID: 18416624BACKGROUND

  • Cenzato N, Nobili A, Maspero C. Prevalence of Dental Malocclusions in Different Geographical Areas: Scoping Review. Dent J (Basel). 2021 Oct 11;9(10):117. doi: 10.3390/dj9100117.

    PMID: 34677179BACKGROUND

  • Devanna R, Felemban NH, Althomali Y, Battepati PM, Ali Alfawzan A, Gupta P. Prevalence of malocclusion among children of the Kingdom of Saudi Arabia - A systematic review and meta-analysis. Saudi Dent J. 2021 Dec;33(8):826-834. doi: 10.1016/j.sdentj.2021.09.005. Epub 2021 Sep 14.

    PMID: 34938022BACKGROUND

  • Grewal H, Sapawat P, Modi P, Aggarwal S. Psychological impact of orthodontic treatment on quality of life - A longitudinal study. Int Orthod. 2019 Jun;17(2):269-276. doi: 10.1016/j.ortho.2019.03.009. Epub 2019 Apr 23.

    PMID: 31028017BACKGROUND

  • Har-Zion G, Brin I, Steiner J. Psychophysical testing of taste and flavour reactivity in young patients undergoing treatment with removable orthodontic appliances. Eur J Orthod. 2004 Feb;26(1):73-8. doi: 10.1093/ejo/26.1.73.

    PMID: 14994885BACKGROUND

  • Hassan AH, Amin Hel-S. Association of orthodontic treatment needs and oral health-related quality of life in young adults. Am J Orthod Dentofacial Orthop. 2010 Jan;137(1):42-7. doi: 10.1016/j.ajodo.2008.02.024.

    PMID: 20122429BACKGROUND

  • Hegde AM, Dwivedi S. Effect of removable orthodontic appliance on taste and flavor perception--a clinical study. J Clin Pediatr Dent. 2007 Fall;32(1):79-82. doi: 10.17796/jcpd.32.1.jt1677554845122u.

    PMID: 18274477BACKGROUND

  • Izabella Dunin-Wilczyńska1, ,. U. Ż. A. M. T. B., (2011). Effects of Palatal Fixed Auxiliary Appliances on the Sense of Taste. Dental and Medical Problems, Volume 48, p. 217-222. https://dmp.umw.edu.pl/en/article/2011/48/2/217/

    BACKGROUND

  • Kiyak HA. Does orthodontic treatment affect patients' quality of life? J Dent Educ. 2008 Aug;72(8):886-94.

    PMID: 18676797BACKGROUND

  • Mueller C, Kallert S, Renner B, Stiassny K, Temmel AF, Hummel T, Kobal G. Quantitative assessment of gustatory function in a clinical context using impregnated "taste strips". Rhinology. 2003 Mar;41(1):2-6.

    PMID: 12677732BACKGROUND

  • Marques LS, Paiva SM, Vieira-Andrade RG, Pereira LJ, Ramos-Jorge ML. Discomfort associated with fixed orthodontic appliances: determinant factors and influence on quality of life. Dental Press J Orthod. 2014 May-Jun;19(3):102-7. doi: 10.1590/2176-9451.19.3.102-107.oar.

    PMID: 25162573BACKGROUND

  • Proffit, W. R., Fields, H. W., Larson, B. E., & Sarver, D. M. (2019). Contemporary Orthodontics. Philadelphia, PA: Elsevier. https://shop.elsevier.com/books/contemporary-orthodontics/proffit/978-0-323-54387-3

    BACKGROUND

  • Razdan P, Sakthivel VS, Naqvi ZA, Goyal V, Tripathi S, Singh S. Alteration in Taste Perception among Young Children during the use of Removable Orthodontic Appliance Therapy. J Contemp Dent Pract. 2017 Jul 1;18(7):607-613. doi: 10.5005/jp-journals-10024-2093.

    PMID: 28713117BACKGROUND

  • Sergl HG, Zentner A. A comparative assessment of acceptance of different types of functional appliances. Eur J Orthod. 1998 Oct;20(5):517-24. doi: 10.1093/ejo/20.5.517.

    PMID: 9825554BACKGROUND

  • Spence C. Multisensory flavor perception. Cell. 2015 Mar 26;161(1):24-35. doi: 10.1016/j.cell.2015.03.007.

    PMID: 25815982BACKGROUND

  • Stewart FN, Kerr WJ, Taylor PJ. Appliance wear: the patient's point of view. Eur J Orthod. 1997 Aug;19(4):377-82. doi: 10.1093/ejo/19.4.377.

    PMID: 9308258BACKGROUND

  • Taruno A, Nomura K, Kusakizako T, Ma Z, Nureki O, Foskett JK. Taste transduction and channel synapses in taste buds. Pflugers Arch. 2021 Jan;473(1):3-13. doi: 10.1007/s00424-020-02464-4. Epub 2020 Sep 16.

    PMID: 32936320BACKGROUND

MeSH Terms

Interventions

Orthodontic Appliances, Fixed

Intervention Hierarchy (Ancestors)

Orthodontic AppliancesOrthodonticsDentistry

Central Study Contacts

Hassan AlHarby, DDS

CONTACT

00966545436150hassan.a.alharby2021@student.riyadh.edu.sa

Deema AlShammery, MDS

CONTACT

deema@riyadh.edu.sa

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate student

Study Record Dates

First Submitted

October 16, 2023

First Posted

October 23, 2023

Study Start

November 1, 2023

Primary Completion

January 15, 2024

Study Completion

February 1, 2024

Last Updated

October 27, 2023

Record last verified: 2023-10